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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-04-27 to 2005-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(p-chlorophenyl)piperidin-4-ol
EC Number:
254-479-8
EC Name:
4-(p-chlorophenyl)piperidin-4-ol
Cas Number:
39512-49-7
Molecular formula:
C11H14ClNO
IUPAC Name:
4-(p-chlorophenyl)piperidin-4-ol
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study reports): JNJ-117676-AAA (T000263)
- Physical state: solid (powder)
- Appearance: White, slight beige amorphous, crystalline, micropowder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: the test item was delivered by the Sponsor with Batch number: CODE: 8693
- Expiration date of the lot/batch: 31 December 2005
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature (range of 20 ± 5 °C), light protected
- Stability under test conditions: no data, but stable under storage conditions
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
Purified water was found to be a suitable vehicle

Test animals

Species:
rat
Strain:
other: HanRcc: Wist (SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd., Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: 11 - 13 weeks
- Weight at study initiation: 185.3 g (mean)
- Fasting period before study: 19 hours (access to water was permitted)
- Housing: in groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
- Diet (e.g. ad libitum): pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 4/05, ad libitum
- Water (e.g. ad libitum): community tap water from Füllinsdorf, ad libitum
- Acclimation period: 2005-04-27 to 2005-05-03 (females, 2000 mg/kg); 2005-04-29 to 2005-05-05 (females, 300 mg/kg); 2005-05-10 to 2005-05-16 (females, 300 mg/kg)


ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: : purified water prepared at RCC Ltd.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL or 0.03 g/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen after a solubility trial which was performed before the study initiation date.
- Lot/batch no. (if required): not applicable
- Purity: reported as purified


MAXIMUM DOSE VOLUME APPLIED:
- 10 mL/kg bw


DOSAGE PREPARATION (if unusual):
- not applicable


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no data
Doses:
2000 mg/kg bw for one group of 3 females, or 300 mg/kg bw for two groups of 3 females each
No. of animals per sex per dose:
three groups each with three females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded; all animals were examined for clinical signs at approximately 30 minutes, 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15; mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15; Body weights were recorded on day 1 (prior to administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
Statistics:
No statistical analysis was used.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - < 2 000 mg/kg bw
Mortality:
One 2000 mg/kg treated animal had to be killed in extremis for ethical reasons approximately 2 1/2 hours after test item application. The two other animals also treated at 2000 mg/kg were found dead approximately 1 1/2 hours after treatment. All 300 mg/kg treated animals survived until the end of the study period.
Clinical signs:
observations of tremors
other:
Body weight:
other body weight observations
Remarks:
The body weights of the animals were within the range commonly recorded for this strain and age.
Gross pathology:
Liquid contents were noted in the stomach of all three animals treated at 2000 mg/kg at their unscheduled necropsy. One 300 mg/kg-treated animal showed congestion of the lungs, whereas no macroscopic findings were recorded in the remaining animals treated at 300 mg/kg at their scheduled necropsies.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The purpose of the study was to assess the acute toxicity of the test substance when administered by a single oral gavage to rats, followed by an observation period of 14 days. The LD50 of the test substance after single oral administration to female rats, observed over a period of 14 days was greater than 300 mg/kg bw and less than 2000 mg/kg bw.